Melia Ellen, English Aislinn, Naughton Bernard D
The School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, The University of Dublin, Dublin, Ireland.
The Centre for Pharmaceutical Medicine Research, Kings College London, London, United Kingdom.
Front Med (Lausanne). 2024 Jul 18;11:1429872. doi: 10.3389/fmed.2024.1429872. eCollection 2024.
Falsified medicines and their international regulation impacts all healthcare sectors and their actors. These regulations aim to strengthen and protect the global pharmaceutical supply chain against falsified medicines. However, an evaluation of the impacts of these regulations on key stakeholders within the legitimate supply chain have not been explored.
This research aimed to evaluate both the positive and negative impacts of falsified medicines regulation on key stakeholders within the global pharmacy sector including including manufacturers, wholesalers, hospital pharmacies, community pharmacy and patients.
This research consists of a systematic review and thematic analysis concerning falsified medicines regulation and the subsequent impacts of existing global regulations on healthcare. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklist were utilized for reporting in this systematic review.
A search of three databases, Embase, ProQuest and PubMed, was undertaken to determine studies applicable to the research question. The Mixed Methods Appraisal Tool (MMAT) was used to assess methodological quality and risk of bias for all included studies.
From the initial 657 studies, a final set of 13 relevant studies were identified. The most frequently reported falsified medicines regulation was the Falsified Medicines Directive (FMD) [ = 11]. The impact of falsified medicines regulation in the literature related to four areas: (1) Financial, (2) Social, (3) Organizational, and (4) Pharmacy Practice. These common themes across the included studies frequently relate to challenges and/or concerns associated with falsified medicines regulation implementation as well as both the logistics and practicality of incorporating falsified medicines regulations into daily operations.
Implementation and enforcement of falsified medicines regulation does not yet appear to categorically fulfill the primary aim of the regulations, to strengthen the drug supply chain. However, in recent years, such regulations have challenged the legitimate pharmaceutical supply change actors as they attempt to successfully implement these regulations. Studies mainly detail the negative impacts of regulation during the implementation phase but with the overall benefit pertaining to the prioritization and enhancement of patient care and safety within the healthcare sector.
假药及其国际监管影响着所有医疗保健部门及其从业者。这些法规旨在加强和保护全球药品供应链免受假药侵害。然而，尚未探讨这些法规对合法供应链内关键利益相关者的影响。
本研究旨在评估假药监管对全球制药行业内关键利益相关者（包括制造商、批发商、医院药房、社区药房和患者）的积极和消极影响。
本研究包括对假药监管以及现有全球法规对医疗保健的后续影响的系统评价和主题分析。本系统评价采用系统评价和Meta分析的首选报告项目（PRISMA）声明和清单进行报告。
对三个数据库Embase、ProQuest和PubMed进行检索，以确定适用于该研究问题的研究。混合方法评估工具（MMAT）用于评估所有纳入研究的方法学质量和偏倚风险。
从最初的657项研究中，最终确定了13项相关研究。最常被报道的假药监管是《假药指令》（FMD）[=11]。文献中假药监管的影响涉及四个领域：（1）财务，（2）社会，（3）组织，以及（4）药学实践。纳入研究中的这些共同主题经常涉及与假药监管实施相关的挑战和/或担忧，以及将假药监管纳入日常运营的物流和实用性。
假药监管的实施和执行似乎尚未完全实现法规的主要目标，即加强药品供应链。然而，近年来，这些法规给合法药品供应链参与者带来了挑战，因为他们试图成功实施这些法规。研究主要详细阐述了实施阶段监管的负面影响，但总体好处是有助于在医疗保健部门优先考虑和提高患者护理及安全水平。
